Kornimate/medical-research-clean huggingface dataset:
safety evaluation of prismocitrate 18 in patients receiving crrt

Conditions: Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT); Acute Kidney Injury (AKI)

Summary: prismocitrate 18 is a continuous renal replacement therapy (crrt) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. the delivery of crrt therapy is provided by the prismax system which includes regional citrate anticoagulation (rca) software to facilitate citrate and calcium compensation prescription. the objectives of this study are: 1) to confirm the safety of prismocitrate 18 in patients receiving crrt using continuous venovenous hemodiafiltration (cvvhdf) or continuous venovenous hemofiltration (cvvh) and 2) to observe that the software and interface for the prismax system version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (rca) (citrate and calcium dosing) during crrt with prismocitrate 18 and intended prescription. the study period of the patient's crrt will be up to 10 days.


Eligibility criteria:
inclusion criteria: * patients must be ≥18 years of age * patients who are candidates for crrt * patients expected to survive for at least 24 hours * patients with a contraindication to heparin or an increased risk of hemorrhage * patient and/or legally-authorized representative has signed a written informed consent form (icf) per 21 cfr part 50.55(e) exclusion criteria: * patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity * patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease * patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a child-pugh liver failure score \>10 * patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/l) * patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/l), or outside of the laboratory reference range (note: it is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation) * female patients of childbearing potential who are pregnant or breastfeeding. (note: all female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study screening must have a negative serum beta human chorionic gonadotropic \[b-hcg\] pregnancy test at screening) * patients who are currently participating in another interventional clinical study
classification and comparison of early-onset and late-onset idiopathic chronic pancreatitis

Conditions: Chronic Pancreatitis; Idiopathic Chronic Pancreatitis

Summary: classification of early-onset idiopathic chronic pancreatitis (eoicp) and late-onset idiopathic chronic pancreatitis (loicp) was proposed based on bimodal distribution of age at onset of idiopathic chronic pancreatitis (icp). however, studies of larger populations prove it may be normal distribution. therefore, the aim of the study is to find what the distribution of age at onset of icp is and whether the classification of eoicp and loicp is meaningful.

idiopathic chronic pancreatitis (icp) patients admitted to the investigator's center from january 2000 to december 2013 were enrolled. characteristics were compared between early-onset idiopathic chronic pancreatitis (eoicp) and late-onset idiopathic chronic pancreatitis (loicp) patients. cumulative rates of diabetes mellitus, steatorrhea, pancreatic stone, pancreatic pseudocyst (ppc), biliary stricture, and pancreatic cancer after the onset and the diagnosis of icp were calculated, respectively. different cut-off values for age at onset of icp were set to classify eoicp and loicp. then differences of clinical courses between eoicp and loicp were compared when classified by distinct cut-off values.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic chronic pancreatitis according to asia-pacific consensus exclusion criteria: * pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis * groove pancreatitis * autoimmune pancreatitis * chronic pancreatic patients with identified etiologies
postoperative pain course after uvulopalatoplasty

Conditions: Snoring; Surgical Procedures, Operative; Pain, Postoperative; Quality of Life

Summary: the aim of this study is to determine the postoperative course including effects on the quality of life following soft palate surgery with radiofrequency knife (raup).

for the treatment of social snoring one common treatment modality is the surgical reconstruction of the soft palate. the procedure is a routine operation performed at nearly all ear-nose- and throat departments in norway. the surgery is done with local anaesthesia in an out-patient setting where the patients' postoperative observation at the hospital is limited to 1-2 hours. as the surgery is done in the sensitive mucosa and palatopharyngeal musculature the postoperative course might be unpleasant. the patients are therefore in the need of regular postoperative pain treatment extending into the 2 first weeks after surgery. at hospitals the uvulopalatoplasty is performed using a radiofrequency knife (raup) after the soft palate has been infiltrated with local anaesthesia (1% xylocain/adrenaline). the incision is done paramedialy to the uvular base and up into the musculature of the soft palate then making a smooth arch toward the pharyngeal tonsil upper limit. the then elongated uvula is amputated to about ½ cm. occasionally, a suture is placed laterally and medially to lift the palate and prevent postoperative scaring. coagulation is done if necessary with light bipolar diathermy. as the postoperative course might be unpleasant after raup it is of interest to study the time course and intensity of pain after surgery when using the standardised postoperative pain treatment at omniasykehuset. the result will be useful in future studies looking at ways to improve the pain treatment after uvulopalatoplasty.

Eligibility criteria:
inclusion criteria: * patients of either sex of caucasian origin who are referred to the hospital for snoring that have been subjected to a sleep study indicating that uvulopalatoplasty might have a considerable affect on the snoring. exclusion criteria: * chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (saids) and non-steroidal anti-inflammatory drugs (nsaids)) apart from standard postoperative analgesic treatment administered by the operator. * patients with diabetes. * patients who due to age or communication skills are considered unable to complete patient forms. * professional evaluation suggests an alteration of the planned surgical area or treatment form. * known or assumed intolerance or hyper sensibility to diclofenac, codeine or paracetamol (standard postoperative analgesic treatment). * consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7

Keywords: uvulopalatoplasty postoperative pain quality of life
effect of yoga breathing exercises versus aerobic exercise on hematological parameters

Conditions: Iron Deficiency Anemia

Summary: is there effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females? the purpose of the study is to investigate the effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females

60 patients with iron deficiency anemia and will receive medical treatment of anemia and dietary advice for 12 weeks . thirty patient from the 60 patients will receive yoga therapy and 50 minutes yoga therapy 6 days a week for 12 weeks while the other 30 patients will receive aerobic exercise for 12 weeks

Eligibility criteria:
inclusion criteria: 1. sixty female patients referred with iron deficiency anemia 2. their age will be ranged from 30-40 years old. 3. all patients have a history of anemia. 4. all patients should be medically stable. 5. the body mass index (bmi) ranged from 25:29.9 kg/m2 6. number of parity not exceed 3 times. 7. period of menses from 3-5 days exclusion criteria: 1. patients with cognitive impairments. 2. all types of anemia except iron deficiency anemia 3. patients with hearing problems. 4. patients with diabetes, hypertension. 5. patients with musculoskeletal, neurological, cardiovascular and respiratory problems 6. patients with mental problems.
flash open trial with therapists in training

Conditions: Trauma, Psychological

Summary: this study will test the eye movement desensitization and reprocessing (emdr) based flash technique and a progressive counting (pc) based variant. emdr-trained therapists will be trained in the standard flash, and pc-trained therapists will be trained in pc flash. in each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. participants will use the subjective units of distress scale (suds) to rate distress pre- and post-treatment.


Eligibility criteria:
inclusion criteria: * therapist trained by trauma institute \& child trauma institute in emdr or pc
genomic grade index (ggi): feasibility in routine practice and impact on treatment decisions in early breast cancer

Conditions: Invasive Breast Cancer

Summary: in this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - genomic grade index (ggi) - in routine clinical practice and its impact on treatment recommendations.

the primary objective of this study was to evaluate the feasibility of implementing genomic grade index (ggi) in community hospitals in belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. ggi would be considered a feasible genomic test if results were obtained in \> 70% of evaluated patients.

Eligibility criteria:
inclusion criteria: histologically confirmed invasive breast cancer meeting the following criteria: * t1, t2, or operable t3 disease * zero to three positive lymph nodes and no distant metastases * operable disease - must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance exclusion criteria: * no other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer * no psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study

Keywords: breast cancer feasibility genomic grade index
impact of an effort rehabilitation program for overweight/obese children/teens on quality of life and wellbeing

Conditions: Pediatric Obesity

Summary: obese and overweight children or teens can join the prevention and care of pediatric obesity and pediatric diabetes organization of mulhouse. those patients who are no longer able to exercize because of their physical condition start an effort rehabilitation program at the organization. the study will evaluate the impact of this rehabilitation program on quality of life and appetency to physical activity for these children and teens.

because of a national obesity plan (2010-2013) initiated by the french government in charge of health, the pediatric obesity and pediatric diabetes organization of mulhouse was created in 2011. this organization is in charge of children or teens with: * severe or growing obesity associated with respiratory, osteo-articular metabolic complications * comorbidities worsened by obesity the organization and the physical medicine and rehabilitation department of the mulhouse hospital have worked together to create an effort rehabilitation program for obese or overweight children. the program, aiming movement rehabilitation, is based on reinforcement and endurance activities in a playful atmosphere and in an important motivational dimension. a medical examination is performed before the first session to confirm the patient's ability to follow an effort rehabilitation program. each session is supervised by a teacher of adapted physical activity.

Eligibility criteria:
inclusion criteria: * bmi \> 97 percentile * at least one of the following symptoms : * respiratory functional signs * orthopedic complications * sleep apnea * cardiovascular complications * metabolic syndrome exclusion criteria: * lack of motivation * uncontrolled psychological issue * ambulatory care more appropriate to treat the same issues * any related psychiatric pathology likely to worsen with weight loss * patient or family not committed to therapeutics program * psychological inability to deal with separation * behavior disorders making collective activity impossible

Keywords: teens effort rehabilitation quality of life wellbeing physical skills assessment
pediatric inguinal hernia repair: are muscle relaxants necessary? endotracheal intubation vs laryngeal mask airway

Conditions: Inguinal Hernia; Endotracheal Intubation; Laryngeal Mask; Muscle Relaxants

Summary: in prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using pirs (percutaneous internal ring suturing) method will be randomly assigned into four groups. gr 1: endotracheal intubation and muscle relaxant, gr 2: endotracheal intubation without muscle relaxant, gr 3: proseal laryngeal mask airway without muscle relaxant, gr 4: proseal laryngeal mask airway with subparalytic does muscle relaxant. apart from standard monitorization, all patients' intragastric pressures will also be monitored. patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

in this prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using pirs (percutaneous internal ring suturing) method will be randomly assigned into four groups. gr 1: endotracheal intubation and muscle relaxant, gr 2: endotracheal intubation without muscle relaxant, gr 3: proseal laryngeal mask airway without muscle relaxant, gr 4: proseal laryngeal mask airway with subparalytic does muscle relaxant. apart from standard monitorization, all patients' intragastric pressures will also be monitored. patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

Eligibility criteria:
inclusion criteria: * children aged 0-18 years * diagnosed with inguinal hernia or communicating hydrocele * due to undergo laparoscopic inguinal hernia repair exclusion criteria: * previous abdominal surgery * comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
clinical pilot-study of proendotecc vascular grafts as superficial femoral artery bypass / interponate

Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease

Summary: this is a multi-center, clinical pilot-study of proendotecc vascular grafts (6, 7 or 8 mm diameter) as superficial femoral artery bypass/interponate. the aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.


Eligibility criteria:
inclusion criteria: * female or male patient from 18 to 89 years of age * superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint), * patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia, * patient has rutherford grade 3, 4, or 5 occlusive vascular disease, * women of childbearing age must have negative pregnancy test prior to inclusion exclusion criteria: * bleeding diathesis * patient has known coagulation disorders including hypercoagulability * presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs) * other than 6-8 mm diameter graft is needed. * patients pad state is in fontaine grade iv, rutherford grade 6 (patient has active infection or pronounced necrosis in the region of graft placement) * patient has an acute embolic arterial occlusion * life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits * patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days * participation in another clinical study less than 30 days prior to inclusion * patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure * pregnant or breast feeding female patients * multiple graft (implant) needed * patients unable to understand the full meaning of the informed consent * subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study * subjects who are imprisoned (according to mpg §20.3) * patients who are lawfully kept in an institution * participation in this trial at an earlier stage * current participation in another clinical trial

Keywords: peripheral arterial disease peripheral vascular disease pad vascular prosthesis revascularization patency blood vessel rutherford abi ankle brachial index vascular graft carbothane proendotecc implantation
optimizing chronic pain management through patient engagement with quality of life measures

Conditions: Chronic Low Back Pain

Summary: this study evaluates the use of a health-related quality of life report based on the spade cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the promis-29 instrument in patients with chronic low back pain. half of the participants will receive the report, while the other half will not.

the health-related quality of life report provides participants with an overall score on the spade cluster and scores on each of its five component scales. the recently released federal pain research strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. it recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. this study primarily aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain. another aspect of the study will be to determine how the health-related quality of life report may impact the physician-patient interaction. this will be assessed using validated measures of physician interpersonal manner, empathy, and communication style, as well as end-of-trial survey data acquired from participants assigned to the experimental group. the survey will include an overall assessment of the report, as well as specific actions attributed to the report.

Eligibility criteria:
inclusion criteria: * chronic low back pain and spade cluster score ≥ 55 exclusion criteria: * absence of chronic low back pain or spade cluster score \< 55

Keywords: back pain quality of life promis-29 precision pain research registry
assessing patient engagement in keratoconus clinical research

Conditions: Keratoconus

Summary: this study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors. in essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. elevating participation rates could expedite the development of innovative treatments for this challenging condition.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged ≥ 18 years old * no prior treatment for keratoconus exclusion criteria: * participant is actively receiving study therapy in another * inability to provide written informed consent * women of childbearing potential without a negative pregnancy test; or women who are lactating.

Keywords: keratoconus
affecting the epidemiology of hiv in uganda

Conditions: Sexual Abstinence; HIV; Contraceptive Usage

Summary: the investigators propose to develop a comprehensive, text messaging-based hiv prevention program for ugandan adolescents 18-22 years of age.

the investigators propose to develop a comprehensive, text messaging-based hiv prevention program for ugandan adolescents 18-22 years of age. the guiding theoretical model is the information-motivation-behavioral skills (imb) model of hiv preventive behavior. intervention development will be iterative: in phase 1, the investigators will identify an intervention content "map." then, online focus groups (fg) will be conduct online with ugandan young adults (n = 40-80) to confirm program components (e.g., social support via text buddy, optimal time of delivery of daily text messages) and saliency of intended program topics. in phase 2, the investigation team will "translate" content into a bank of text messages that will be reviewed for comprehensiveness and inclusion of the most pertinent topics. the final pool of messages among ugandan young adults will be tested in the content advisory council (cac; n = 30) to assess their reactions to the content, scope, style, and tone of the messages. in phase 3, the investigators will merge the content with the software program developed to deliver the intervention and then internally conduct a functionality test of the programmed messages. following, the protocol and program will be tested in a beta test of 20 ugandan adults. in phase 4, the investigators will test the intervention in a randomized controlled trial of 200 ugandan young adults randomly assigned to either the intervention (n = 100) or control (n = 100) arms. the main outcome measures will focus on feasibility (e.g., recruitment and retention rates) and acceptability (e.g., text buddy). the primary efficacy outcome measures, measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b) sustained sexual abstinence, and (c) increased hiv testing rates. specific aims are as follows: specific aim 1: design a 6-week text messaging-based hiv prevention and healthy sexuality program for adolescents 18-22 years old. specific aim 2: pilot test the intervention for feasibility and acceptability among 18- to 22-year-old ugandans. specific aim 3: obtain preliminary data needed for a larger-scale controlled trial services study to examine program efficacy.

Eligibility criteria:
inclusion criteria: * living in uganda * aged 18-22 years * able to read english * exclusive owner of a cell phone * using text messaging for at least 6 months * intended to have the same phone number or the next six months * able to access the internet (to complete online surveys) * able to provide informed consent exclusion criteria: * no other exclusion criteria will be applied

Keywords: technology adolescent developing country hiv prevention mhealth